Trials / Completed
CompletedNCT00005955
Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 4 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.
Detailed description
OBJECTIVES: * Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors. * Determine the toxicity of this treatment in these patients. * Determine the overall survival in these patients for 18 months following the study after receiving this treatment. OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other). Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy. PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | temozolomide |
Timeline
- Start date
- 2000-08-01
- Completion
- 2002-09-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005955. Inclusion in this directory is not an endorsement.